FB-TW

Thursday, February 21, 2008

Doctors in Denial about Patients' Side Effects from Prescription Drugsby David Gutierrez (NaturalNews)

Doctors are overwhelmingly inclined to dismiss patients' complaints about potential side-effects from cholesterol-reducing statins and rarely report those complaints to the FDA, according to a survey conducted by researchers from the University of California at San Diego and published in the peer-reviewed journal Drug Safety.

The study suggests that doctors have a tendency to attribute patients' complaints to age or other factors unrelated to prescription drugs, and that this problem may extend to drugs other than statins.

"Person after person spontaneously [told] us that their doctors told them that symptoms like muscle pain couldn't have come from the drug," said lead researcher Beatrice Golomb. "We were surprised at how prevalent that experience was.

"The researchers solicited survey respondents through advertisements and over the Internet, including on web sites where patients had complained about side effects from the drugs. Most of the respondents lived in the United States, and the average age was in the early 60s. The majority of respondents reported having complained to their doctors about problems that arose after they began the drugs, particularly memory and attention problems or tingling and numbness in the extremities. But few doctors made a connection between these complaints and the drugs, even when the symptoms were documented side effects.

"Overwhelmingly, it was the patient that initiated that conversation," Golomb said. Doctors instead tended to blame the symptoms on aging or even to dismiss them as insignificant or imaginary.

As much as 30 percent of patients taking statins may experience muscle pain or other side effects. But these numbers may be on the low end if doctors are not reporting side effects when they occur.

The FDA relies primarily on doctors to fill out "adverse event reports" to help monitor drugs after they have hit the market. Patients can also file reports at http://www.FDA.gov/medwatch but few people are aware of this program. In contrast, other countries such as New Zealand rely heavily on data from patients to continue monitoring drugs.

According to Golomb, one-fifth of all FDA-approved drugs will eventually be withdrawn from the market or given black-box warnings due to severe side effects.

"The authors found no clinical trial subgroup analyses or valid cohort or case–control analyses suggesting that the degree to which LDL cholesterol responds to a statin independently predicts the degree of cardiovascular risk reduction."Here are the 'Key Summary Points"

No high-quality evidence could be found that suggests that titrating lipid therapy to recommended low-density lipoprotein (LDL) cholesterol targets is superior to empirically prescribing doses of statins used in clinical trials for all patients at high cardiovascular risk.

Studies addressing benefits of achieving LDL cholesterol goals have had avoidable problems, such as reliance on ecological (aggregate) analyses, ignoring statins' other proposed mechanisms of action, and not accounting for known confounders (especially healthy volunteer effects).

Much more reliable evidence on currently proposed LDL cholesterol goals could be expeditiously produced by conducting cohort analyses of past statin trials that control for statin dose and pill adherence.

Dichotomous comparisons (such as comparing those who reach goal vs. those who do not) can mistakenly suggest that not achieving the treatment goal results in moderate risk when in fact almost all of the risk is caused by large deviations from the ideal goal.

Proposals for treatment goals should also consider the risks, patient burden, and societal costs of the treatments that may be needed to reach those goals.